Crohn’s disease (CD) and ulcerative colitis (UC) are two gastrointestinal autoimmune/inflammatory indications that commonly feature treatment with biological therapies. The U.S. CD market consists of five approved biologics, and the UC market consists of four; the most recent agent—Takeda’s Entyvio (vedolizumab; CD and UC)—received FDA approval in May 2014. In both CD and UC, Janssen’s Remicade (infliximab) continues to lead the U.S. market in sales and patient share as the therapy to beat for agents targeting patients refractory to conventional, less-costly agents, followed by AbbVie’s Humira (adalimumab). Despite the positive impact of these TNF-α inhibitors on CD and UC treatment, U.S. gastroenterologists indicate that novel agents are still needed that offer the basic clinical attributes of inducing and maintaining clinical remission at higher rates. With the recent launch of Entyvio and the anticipated launches of Janssen’s Stelara (ustekinumab) for CD and Pfizer’s Xeljanz (tofacitinib) for UC in the near future, the competitive environment will intensify, presenting physicians with additional therapy options for moderate-to-severe disease.
In this report, we gauge physicians’ and payers’ opinions of current biologics and emerging therapies for CD and UC to anticipate potential changes in the prescribing patterns and reimbursement climate. We focus on the available TNF-α inhibitors Remicade, Humira, Janssen’s Simponi (golimumab), and UCB’s Cimzia (certolizumab pegol); the cell adhesion molecule inhibitors Biogen Idec’s Tysabri (natalizumab) and Entyvio; and the emerging therapies Stelara and Xeljanz. In addition, we discuss physicians’ and payers’ opinions of biosimilars for infliximab and adalimumab, which we anticipate will launch during the same time frame as the branded agents, and how they will affect potential patient share of currently available and emerging therapies.